BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 18298836 · Received December 11, 2023

    Report

    Report Number
    3004464228-2023-34918
    Event Type
    Malfunction
    Date Received
    December 11, 2023
    Date of Event
    November 15, 2023
    Report Date
    March 15, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000114
    PMA / PMN Number
    K203768
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D1 - BRAND NAME CHANGED TO OMNIPOD 5 POD. D2B - PROCODE CHANGED TO QFG. D4 - MODEL # CHANGED TO PT-000435. D4 - CATALOG # CHANGED TO POD-BLE-H1-520. D4 - UNIQUE IDENTIFIER (UDI) # CHANGED TO (B)(4).

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PINK SLIDE INSERT DID NOT MOVE FORWARD INDICATING THAT THERE WAS A NEEDLE MECHANISM FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54105 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female